FDA Label for Publix Stimulant Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANCY OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Publix Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Bisacodyl, USP 5 mg
Purpose
Stimulant laxative
Use
▪ for temporary relief of occasional constipation and irregularity▪ this product generally produces a bowel movement in 6 to 12 hours
Do Not Use
if you cannot swallow without chewing.
Ask A Doctor Before Use If You Have
▪ stomach pain, nausea or vomiting▪ a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
▪ do not chew or crush tablet(s)▪ do not use within 1 hour after taking an antacid or milk▪ it may cause stomach discomfort, faintness and cramps
Stop Use And Ask A Doctor If
▪ you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.▪ you need to use a laxative for more than 1 week
If Pregnancy Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).
Directions
take with a glass of water
adults and children 12 years of age and over | 1 to 3 tablets in a single daily dose |
children 6 to under 12 years of age | 1 tablet in a single daily dose |
children under 6 years of age | ask a doctor |
Other Information
• store at room temperature• Protect from excessive humidity
Inactive Ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 41415-116-25
*Compare to the Active Ingredient in Dulcolax®
Laxative
BISACODYL, USP 5 mg
STIMULANT LAXATIVE
Overnight relief
Gentle, dependable, constipation relief
25 COATED TABLETS
*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax®.
TAMPER EVIDENT: Do not use if any individual unit is broken or open.
IMPORTANT: Keep this carton for future reference on full labeling. |
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
1-888-267-3037 publix.com
PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUE MONEY BACK
* Please review the disclaimer below.